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SURE DENT CORPORATION

South Korea·KR-MF-000018662

Last updated September 17, 2026

What SURE DENT CORPORATION makes

Sure Dent Corporation manufactures non-medicated gingival retraction cords, including variants like the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These products are designed to isolate gingival tissue during dental procedures, such as impressions or restorations, to improve accuracy and margin definition.

The company’s portfolio includes devices classified as Class I and Class IIa under EU regulations, with products registered in the EUDAMED database. The manufacturer is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sure Dent Corporation manufacture?

Sure Dent Corporation specializes in non-medicated gingival retraction cords, such as the R&S Retraction Cord, Kent dental Retraction Cord, and Inline-Cord. These devices are used in dentistry to temporarily retract gum tissue during procedures like impressions or restorations, ensuring clearer margins and better accuracy.

Where is Sure Dent Corporation based?

Sure Dent Corporation is headquartered in South Korea. The company’s location influences its regulatory compliance, particularly for markets like the European Union, where its devices are registered in the EUDAMED database.

Which regulatory registries list Sure Dent Corporation’s devices?

Sure Dent Corporation’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry allows healthcare professionals and regulators to verify the manufacturer’s details and device classifications.

How are Sure Dent Corporation’s devices classified under EU regulations?

Sure Dent Corporation’s devices fall into Class I and Class IIa classifications under EU medical device regulations. The classification depends on factors like the device’s intended use and potential risk level—gingival retraction cords are generally lower-risk but may require additional scrutiny depending on design or materials.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: South Korea
Address: 52, #809, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
Website: www.suredent.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 31 737 4720
PRRC Contact: Sungjun Charles Bae
EUDAMED SRN: KR-MF-000018662
FDA FEI Number: 3001421500
DUNS Number: —

Catalogue (1042)

Page 20 of 21

Device	Model / Reference	Registries	Class	Status
EdgeEndo .04 Paper Points	SPP1504-1	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L30.06	EUDAMED	Class IIa	Active
Edge Taper Gutta Percha Points	ETGPF5-1	EUDAMEDFDA UDI	Class IIa	Active
Absorbent Paper Points	P910 70.06	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LBX2-X5	EUDAMED	Class IIa	Active
Edge File X7 .04 Gutta Percha Points	X7GP04AST-1	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L20.06	EUDAMED	Class IIa	Active
Inline® Absorbent Paper Points	IP53/M	EUDAMED	Class IIa	Active
Procodile® Paper Points	PPPR04.000.045	EUDAMEDFDA UDI	Class IIa	Active
Centra® Endo Paper	SD53ASS	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP04/15-40	EUDAMED	Class IIa	Active
Exotec Pointes Papier Absorbantes, ISO Color, ISO Taper	EN02863	EUDAMED	Class IIa	Active
EdgeEndo .04 Paper Points	SPP2004-1	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 LB45.05	EUDAMEDFDA UDI	Class IIa	Active
Septaline Endodontie Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	PL-SEP-33E.1040	EUDAMED	Class IIa	Active
Procodile® Guttapercha Points	GPPR06.000.025	EUDAMED	Class IIa	Active
Septaline Endodontie Gutta Ponts, Color-End-Gutta, ISO-Taper, Vario-Taper	PL-SEP-33E.0435	EUDAMED	Class IIa	Active
PlanBDental® minikut® Paper Points	1670525	EUDAMEDFDA UDI	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5019516EU	EUDAMED	Class IIa	Active
FQ Guttapercha Points	GPFQ06.000.030	EUDAMEDFDA UDI	Class IIa	Active
Steriblue Paper Points, Color-End-Paper, ISO-Taper, Vario-Taper	SB-PPTCO015	EUDAMED	Class IIa	Active
Inline® Gutta Percha Points	IP50/XL	EUDAMED	Class IIa	Active
Bio GP Points	G906 B40.04	EUDAMED	Class IIa	Active
Paper Points	PP04.000.035	EUDAMEDFDA UDI	Class IIa	Active
EdgeOne Fire Gutta Percha Points	EOFGPAST-1	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 LX4	EUDAMED	Class IIa	Active
CrownTaper Paper Points	121F5	EUDAMED	Class IIa	Active
B-4U Gutta Percha Points	G906 LBF12/Finisher Asst	EUDAMEDFDA UDI	Class IIa	Active
Inline® Absorbent Paper Points	IP51/90-140	EUDAMED	Class IIa	Active
FQ Paper Points	PPFQ04.000.020	EUDAMED	Class IIa	Active
Gutta Percha Points	G906 45-80/.04	EUDAMEDFDA UDI	Class IIa	Active
CrownOne GuttaPercha Points	12125	EUDAMED	Class IIa	Active
Procodile® Paper Points	PPPR06.000.025	EUDAMED	Class IIa	Active
Wieder® EndoGutta+	WI04 20	EUDAMED	Class IIa	Active
Edge File X7 .06 Gutta Percha Points	X72506GP-1	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Points	G906 60.06	EUDAMEDFDA UDI	Class IIa	Active
Bio GP Points	G906 B45.06	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 L20-45/.04	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 L30.02	EUDAMED	Class IIa	Active
Direct Gutta Percha Points	200022	EUDAMED	Class IIa	Active
Gutta-Percha Points	24004	EUDAMEDFDA UDI	Class IIa	Active
TotalFill® BC PointsTM 150 Series Bioceramic Gutta Percha	5027286EU	EUDAMED	Class IIa	Active
EndoSequence® BC PointsTM Bioceramic Gutta Percha	5019510EU	EUDAMED	Class IIa	Active
Absorbent Paper Points	P910 45-80/.06	EUDAMED	Class IIa	Active
Wellsamed Guttapercha Points	WGP330 ISO30 Blau	EUDAMED	Class IIa	Active
Gutta Percha Points	G912 140.02	EUDAMEDFDA UDI	Class IIa	Active
Rachelendo Paper Points	P910 L60.04	EUDAMED	Class IIa	Active
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper	SB-PGVTF2	EUDAMED	Class IIa	Active
Exotec Pointes de Gutta Percha, ISO Color, ISO Taper	EN02630	EUDAMED	Class IIa	Active
Bio GP Points	G906 LB1.0FR25-R50	EUDAMED	Class IIa	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sure Dent Corporation US